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目的:探讨低剂量白介素-2(IL-2)联合肝动脉化疗栓塞术(TACE)在CT引导下行射频消融术(RFA)(RFA)在≥5cm的原发性肝癌的疗效和安全性。方法:2010年10月至2013年9月入组初治的原发性肝癌患者,随机分入低剂量IL-2联合RFA+TACE组(A组)或单纯RFA+TACE组(B组);患者至少有1个肿瘤最大径≥5cm。D1行TACE术。D5±2行RFA术。A组患者自D10连续皮下注射重组人白介素-2 50万单位QOD,共8周。主要观察终点为至疾病进展时间(TTP);次要观察终点为客观有效率(ORR)、总生存期(OS)和安全性。结果:共50例患者入组,A、B组均25例。患者中位年龄为55岁。中位随访期为518d(91~1227d)。IL-2相关的不良事件主要为注射部位硬结(64%)、低热(48%)和乏力(36%)。TACE联合RFA治疗相关的不良事件多为轻至中度或一过性,最常见的包括发热(88.0%)、ALT及AST升高(均为80.0%),疼痛(76.0%)和胆红素升高(66.0%)。其中III度疼痛10例,III度ALT和AST升高各5例。两组之间在微创治疗的安全性方面无显著差异。总ORR均为74.0%,其中CR 11例,PR26例。1年和2年生存率分别为67.8%和52.9%。两组之间在ORR和OS方面无差异。但是,A组较B组TTP显著延长(301d比153d,P=0.047)。在多因素分析中,IL-2并未改变患者预后或疗效。结论:低剂量IL-2可能会进一步提高RFA+TACE在≥5cm的原发性肝癌的疗效,且耐受性良好。需要进一步扩大样本量、探讨更高剂量或更长疗程IL-2在此类患者的作用。
Objective: To investigate the efficacy and safety of low-dose interleukin-2 (IL-2) combined with transcatheter arterial chemoembolization (TACE) in the treatment of primary hepatocellular carcinoma with radiofrequency catheter ablation (RFA) ≥5 cm under CT guidance. Methods: Patients with primary hepatocellular carcinoma (HCC) who underwent primary treatment from October 2010 to September 2013 were randomly assigned to receive either low dose IL-2 plus RFA + TACE (group A) or RFA + TACE alone (group B). Patients with at least 1 tumor diameter ≥ 5cm. D1 line TACE surgery. D5 ± 2 lines RFA surgery. A group of patients from D10 continuous subcutaneous injection of recombinant human interleukin -2 500000 units QOD, a total of 8 weeks. The primary end point was time to disease progression (TTP); secondary end points were objective response (ORR), overall survival (OS), and safety. Results: A total of 50 patients were enrolled in the study, and 25 patients in both A and B groups. The median age of patients was 55 years. The median follow-up period was 518 days (91-1227 days). The major adverse events associated with IL-2 were induration at injection site (64%), hypothermia (48%), and weakness (36%). TACE combined RFA treatment-related adverse events were mild to moderate or transient, the most common include fever (88.0%), elevated ALT and AST (80.0%), pain (76.0%) and bilirubin Increase (66.0%). Among them, 10 were Grade III pain, 5 were Grade III ALT and AST. There was no significant difference in the safety of minimally invasive treatment between the two groups. The total ORR was 74.0%, of which CR 11 cases, PR26 cases. The 1-year and 2-year survival rates were 67.8% and 52.9% respectively. There was no difference in ORR and OS between the two groups. However, TTP was significantly longer in group A than in group B (301d vs 153d, P = 0.047). In multivariate analysis, IL-2 did not change the patient’s prognosis or efficacy. Conclusion: Low dose of IL-2 may further improve the efficacy of RFA + TACE in patients with primary liver cancer ≥ 5cm and is well tolerated. There is a need to further expand the sample size to explore the role of higher doses or longer courses of IL-2 in such patients.